Clinical Trial for Metastatic Brain Cancer Launching at Sylvester

10:10 May 17, 2010

Researchers at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine have just received approval to begin enrolling patients in a Phase I clinical trial involving patients with tumors metastatic to the brain. The novel therapy is based on the laboratory discovery of a drug by Sheldon Greer, Ph.D., professor of microbiology and immunology, biochemistry and molecular biology, and radiation oncology, which can lead to a better radiation effect.

The trial, which is funded in part by the National Cancer Institute (NCI) of the National Institutes of Health, will be led by May Abdel-Wahab, M.D, PhD, associate professor of radiation oncology and is expected to enroll 18 patients. The study is supported by the SCCC and Alan Pollack, M.D., Ph.D., professor and chairman of radiation oncology at Sylvester, who will also take a lead role in the study. This trial centers on the use of Cytochlor, a compound that sensitizes tumor tissue during radiation treatment. Greer developed it several years ago with funding from the NCI which also tested it thoroughly, including preclinical studies to establish the safety. Published, NCI-funded studies with solid tumors in 13 model systems, displayed great effectiveness and safety of the treatment.

Patients with brain metastases today have more options with the availability of radiosurgery and the willingness of neurosurgeons to operate on single lesions, which is supported by studies and evidence-based medicine. However, Wahab points out that “the prognosis and control of brain metastases still remains a challenge with many patients eventually succumbing to their disease or developing progressive neurologic deterioration from lack of local control in the brain.” She adds that “treatments that enhance the effect of radiation on these brain metastases are urgently needed to improve the outcome and quality of life for these patients”.

Seventy percent of cancer patients are treated with radiation, but that therapy can damage surrounding tissue. In addition there are still concerns with progression, recurrence and metastasis of the disease. Cytochlor is able to recognize and target two highly specific enzymes found markedly increased in diseased cells. Once Cytochlor enters those cells, it is transformed into a chemical that is incorporated into tumor DNA. When radiation is applied, the transformed DNA is fragmented to a much higher degree than it would be with just radiation alone.

By adding Cytochlor to the standard radiation regimen, preclinical studies have shown that a dose of 70 units of radiation can be as effective as a dose of 210 units in terms of tumor control without damage to normal tissue

“Cytochlor technology promises to help control these brain lesions and allow a differential increase in radiation effect in tumors as compared to normal brain tissue” says Wahab. “If prior experimental results are confirmed this would be an exciting advance in management of these tumors.”

Greer believes adding Cytochlor “will allow radiation oncologists to be more aggressive in targeting these tumors.” Deborah Heros, M.D., associate professor of clinical neurology and co-leader of the Neuro-oncology Site Disease Group at Sylvester, and Lynn Feun, M.D., professor of clinical medicine and member of the Neuro-oncology Site Disease Group will also be involved in the trial. This Phase I study is expected to take two years to complete and will “pave the way to apply Cytochlor Technology to tumors of the breast, lung, colon/rectum, head and neck and other solid tumors,” adds Greer.

In addition to the NCI, the trial is being funded by Sylvester and the Woman’s Cancer Association of the University of Miami. For more information about the clinical trial with Cytochlor, please call 305-243-4200.

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